The goal of this clinical research study is to learn if there is a difference in patients' quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after surgery on the liver and/or pancreas. Researchers want to learn which method helps people to recover more completely and more quickly after surgery.

The 2 kinds of pain control are intravenous (IV) pain management and epidural pain management.

Pain scores averaged for each participant, and compared between thoracic epidural analgesia (TEA) and intravenous patient controlled analgesia (IVPCA) groups at specific time points as follows: pain scores for the first 6 hours after surgery, pain scores for the next 18 hours after surgery, pain scores for each subsequent 24 hour period after surgery until postoperative day 5 or epidural removed, whichever occurs first. Numeric/Visual Pain Scale (0-10) where 10 is highest level.

Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Other Name: Survey

Behavioral: Pain Assessment

Hourly post surgery rating level of pain on a scale of 0-10.

Experimental: Epidural Pain Management

Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Procedure: Thoracic Epidural Analgesia (TEA)

Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.

Behavioral: Questionnaires

Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.

Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement.

Exclusion Criteria:

Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver or pancreatic surgery.

History of chronic pain, long-term narcotic use or being considered for chronic pain consultation postoperatively.

Anaphylaxis to local anesthetics or narcotic.

Previous or current neurologic disease affecting the lower hemithorax or below.

Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia, except for TIVA (total intravenous anesthesia).

Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion.

Ongoing use or planned peri-operative use of anticoagulants (not including DVT prophylaxis).

Known bleeding diathesis or coagulopathy.

Educational, psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barrier that would preclude accurate assessment of postoperative pain and/or ability to answer questionnaires (need to be able to read, comprehend, and answer questions).

Inability to comply with study and/or follow-up procedures.

Patient refusal to participate in randomization.

Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438476